Medical device systems implemented network scheme for remote patient management

ABSTRACT

A system and method for computer enabled network patient management of medical devices used in chronic disease management. Utilizing web site and push alert notification of alert level physiologic data derived via analysis of continuous stream wireless data transmissions from a patient, a full cycle improvement over existing modalities is achieved. Proxy and medical device user integration and access is enabled to achieve further contribution to the technical advantages of the system.

RELATED APPLICATIONS

This application claims priority from Provisional Application Ser. Nos.60/228,961, 60/228,674, 60/228,686, 60/228,685, 60/228,645, 60/228,699,60/228,698, 60/228,697 and 60/228,696, all filed on Aug. 29, 2000, andalso from application Ser. No. 09/935,019, filed Aug. 22, 2001, and is acontinuation of application Ser. No. 09/943,193, filed Aug. 29, 2001.

FIELD OF THE INVENTION

The invention relates to medical devices implemented and communicablethrough network systems such as the internet. More specifically, theinvention relates to patients wearing implantable or externally mountedmedical devices in which the devices are communicable to remotehealthcare professionals or expert centers for a variety of purposes.

BACKGROUND OF THE INVENTION

Medical devices such as cardiac systems, drug delivery systems,neurological products and similar other products are implanted inpatients for various clinical reasons. Some of these devices may collectand document data on a continuous basis. However, the state of the artis currently to ask patients to see their doctors or other healthprofessionals on a regular basis to retrieve and check the physiologicaldata collected in these devices.

As medical devices become very sophisticated, in both reliability andmaintainability, the need for patients to visit their doctors on aregular basis may not be required by coverage plans or for otherrationale. Various attempts to remotely engage or monitor patients ormedical devices/systems have been suggested, such as for example thosegenerally described in U.S. Pat. Nos. 6,261,230; 6,206,829; 6,221,011B1; 6,203,495 B1; 6,250,309 B1; 6,168,563 B1; 6,108,635; 6,101,478;6,050,940; 6,004,276; 5,987,519; 5,911,687; 5,781,442; 5,752,976;5,633,910; 5,619,991; 5,544,661; and 5,508,912. However, for patientswith chronic disease, the management of the disease has become acritical aspect which affects both the cost of health care and thequality of life of the patient. Accordingly, patients with implantablemedical devices or externally mounted devices that monitor criticalmedical data are either kept in hospitals or the patients are requiredto visit their physicians on a very regular basis.

Accordingly, a data transfer and review system that enables doctors andphysicians to monitor patients on an as-needed basis and as frequentlyas possible, while allowing patients to stay at home, is a highlydesirable service. Such a service would also enable the patient to haveaccess to their own personal data by enabling real time data managementand review by professionals as well as the patient. Further, medicaldevices could be designed to enable patients to be interactive with thedevices that are monitoring their physical and medical parameters suchthat the patient could also be involved in managing their disease on aday-to-day basis. More specifically, if patients are allowed to haveaccess both to the operation of their device and reports that are storedin them, they may have sessions with their doctors and will also bewell-informed in managing their disease, thereby becoming activepartners in the management of their own disease. Various economicopportunities may also arise from such accomplishments.

Various online systems or data mining systems are also known anddescribed generally in U.S. Pat. Nos. 6,260,050; 6,253,193; 6,205,437;6,192,114; 6,112,194; 5,819,092; and International Publication WO01/22265.

SUMMARY OF THE INVENTION

An internet- or equivalent-based system and method for a service isdisclosed which connects a remote patient to a database network formedical device data exchange and review. The system and method includesproviding a web-site having a user interface wherein the user interfaceincludes a secure sign-in input to access a medical device databasenetwork site, receiving at the web-site inputs associated with aspecific medical device and patient, confirming the identity of themedical device and the patient, and enabling the patient to access thedatabase to use the service. A further aspect of this system and methodof doing business is to connect remote users to a database network formedical device data exchange and review by identifying authorized usersto access the database network and generating advantages, includingrevenue streams of a type and quality not previously possible.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a patient with exemplarimplanted medical device components interfacing with a remote patientmanagement network.

FIG. 2 is a schematic diagram of the system and data flow of theinvention.

FIG. 3 is a schematic diagram of the system and data flow of theinvention.

FIG. 4 is a schematic diagram of the system and data flow of theinvention.

FIG. 5 is a decision making flow chart of the method of the invention.

FIG. 6 is a schematic diagram of multiple embodiments of the invention.

FIG. 7 is a schematic diagram of multiple embodiments of the invention.

FIG. 8 is a schematic diagram of another embodiment of the inventionapplied to medical procedural facilities.

DESCRIPTION OF THE INVENTION

Attempts to provide improved healthcare to patient populations usingtechnological methods have met with varying degrees of success. Indeed,however, a very critical problem has emerged in most such efforts. Thepatients and healthcare providers alike risk increased isolation as theuse of technology increases. This isolation and sense ofde-personalization in the healthcare system is often a chief complaintof patients, as well as a source of potential conflict which couldactually impede the formation of candid dialogue which is at the core ofthe best models of patient-physician interface.

Another problem exists in that no actual system for full-cyclehealthcare enablement exists without substantial human intervention fordata handling. Although various patents suggest systems and methods foreither direct healthcare system improvement or revenue generatingsystems and methods which might be useful in healthcare providing (suchas those noted above), these are essentially inoperative or impracticalschemes.

Assignee of the Applicants (Medtronic, Inc.) has developed medicaldevices that are able to detect large amounts of valuable patientspecific information and process that information so as to decidewhether one or more specific actions is appropriate, including forexample whether applications of therapy or ongoing diagnosis is merited.This is technology that has emerged in application of implantablemedical devices over the last several decades, and has transformed manylives due to its use by Medtronic and other companies. However,Applicants have now identified new and improved mechanisms by which thetechnical means of harnessing the ongoing and simultaneous revolutionsin medical device technologies and information technologies to achieve anew level of patient and healthcare provider satisfaction, quality ofcare, improved service, improved efficiencies and improved economics isrealized. This combination of new technical processes has overcome thecombined technical problems associated with: sensing highly specificsignals, parsing and validating high volumes of data, power managementof implanted medical devices, bandwidth allocation to integrate alllevels of a web-enabled network among multiple foreign users, timing andstructures of signals and processing, accessibility and security,display limitations and demands, data routing in multiple pathsincluding wireless paths, partial user unfamiliarity with technology,partial user incapacity, automatic assessment and further handling ofindividual device user data, non-integrated clinical guidelines, andother challenges. The technical effect of the selected protocols alongwith the application of advanced information technology has resulted ina significant technical contribution to the art of integratednetwork-based signal and resource management for programmable and highrelevance detected data signals.

Applicants have recognized that a remarkable innovation is achieved indeeply utilizing the now very robust data collection capabilities ofvarious medical devices and integrating that (explicit and/or implicit)information (either before, during or after analyzing or processing theinformation) into a data network. This causes integration of the patientand healthcare providers, or others, into a collaborative effortresulting in patient-specific healthcare improvement and very dynamicsystem efficiencies. This is a pioneering effort in identifying acombination of historic problems, applying technical methodology tocombine the best medical and information technologies resulting in asolution which transforms the way resources are allocated, which in turnleads to improvements for care of patients with various diseases andconditions, particularly those having chronic conditions.

At one level, the contributions of this invention enable economicfunctionality to attach to highly innovative technical solutions. Thesetechnical solutions to patient care and chronic monitoring yield data inseeming orders of magnitude greater in quality and quantity than in justthe recent past. For example, Applicants' devices automatically sense,retrieve, transmit, process, and store greater than 10¹⁰ heart beats(i.e. cardiac rhythm elements) in a time of just a small number ofhours, continuously over an extensive patient population. When this datais combined with data obtained and automatically processed duringcardiac procedures in operating or emergency rooms, then the volume ofthis rich database is further enlarged. When this data is analyzed,automatically, with software-based algorithms and other tools, then thedata is transformable to various knowledge-enhanced value-added formats.Such formats may be of various types. For example, signal structuringand data formatting (either prior to and/or as a consequence of initialprocessing of transmitted physiological data) may enable different usersof the different formats to have resultant data-based tools availablefor use in numerous different applications or tasks. Examples includedifferent uses and/or formats of mined physiologic data to be used withgreat advantage and economic value by: physicians, health care systems,information networks (from which various laboratories access highrelevance information), Disease Management Organizations (which enablesvery high quality patient interactions use of point of care,instruments, and timely clinical guidelines), internet users, (internetcompanies, health sites, patient advocacy groups, clinical trialorganizations, pharmaceutical companies and individual patient websites), retailers, and medical product or device companies (for researchand development, product planning, post-market surveillance, sales andmarketing, and clinical database work). These users require manydifferent tools, forms of data, for individual and often interactiveproduction of their services and other products. Accordingly, a providerof high relevance data-based products, either raw or rendered, createssubstantial value within numerous systems, each of which is subject toits own economic rules and metrics. Regardless of any differences orsimilarities among these data users, they each receive a value-addedproduct for their constituencies when the information flow or mereavailability of this data is enabled.

In addition to the data and the data flow, there are various new usesfor this physiologic data which occur as a result of the underlyinginventions disclosed herein, and which will be discussed further below.Generally, these innovations create knowledge enhanced value,integration enhanced value, and timing enhanced value. These valueenhancements in turn enable previously unknown services and products tobe provided to various consumers, such as knowledge repositories; datamining tools; academic research tools; surgical techniques; tools, andplanning; device and service-assisted outcomes monitoring andimprovement; and mapping or visualization tools. When previouslyinaccessible or non-useable data of high relevance is rendered availableand in appropriate structure or format, then the above advantages aremade possible. As such, the technical advantages and contributions ofApplicants is realized.

In one example, patients having advanced cardiovascular disease (andtheir care givers) may utilize one aspect of this invention to greatadvantage. Using one or more medical devices 14, such as the implantablecardiac-related devices known as either the Medtronic Chronicle deviceor the GEM III DR device, shown in patient 20 of FIG. 1, a patient'scardiac system is closely monitored. This figure also illustratesalternate examples of device 14 which includes neurologic device 14 anddrug infusion device 14 as well. The invention may utilize a device suchas those noted above which is implanted for sensing directly in acardiac chamber 25, and which may have more data acquisition capabilityand processing power than any other known implantable on earth, or evena more limited capability device. Such a powerful data acquisitionplatform is able to store a wealth of information regarding cardiac andoverall patient physiologic data in the onboard RAM of the device thatcan be uploaded through wireless technology, such as radio frequency(RF) telemetry, telemetry B or C, or the like. Following acquisition ofthis medical data from inside the body, then advanced information andcommunication technologies are utilized to format and communicate thisinformation to other locations or users in a manner which eliminates orvirtually obviates human intervention for various levels of processingof the physiologic data.

In one embodiment, another device, shown in representative manner asdevice 44 in FIG. 1, is arranged to be near the patient and to obtainthe information from the implanted device and transmit the data to aremote network. Device 44 may be alternately described as a remoteinterrogator or by other terminology, which is not meant to limit itsactual technical characteristics in any way, but rather to identify adata communication device for use with medical devices as generallydescribed herein.

As shown in FIGS. 1-7, a secure transmission of the physiologic datafrom the patient then occurs, with the data flowing to a robust networkwhere it can be stored, processed, analyzed and presented for viewingvia a web browser or other interfaces. These technologies have beencombined and improved with the specific purpose of providing a reliable,scalable, secure and accessible system for worldwide real-time use ofthe patient's data. This is an extraordinary, full cycle, breakthroughover known limited systems for disease and patient management. Indeed,this invention re-organizes and prioritizes patient care in a manner notpreviously known along a new model of data and human interaction. In thecardiac example above, information about the patient's heart is onlineand accessible at all times. The system provides the physician andothers with a continuous, longitudinal record of cardiac status ratherthan the snapshot, or limited view, that is received when the patientcomes into a clinic. This is also real-time and continuous, rather thanreactively responsive and subject to any specific event or to knownmonitoring device availability or limitations. Physicians and otherusers may then utilize this new system and methods to implement timely,systematic therapeutic regimens for their patient—as well as for otherpurposes. It is recognized that either the virtual or the physicallocations of certain elements of this system, and methods of performingthe services and advantageous steps of the invention, may be optionallydetermined to occur in either one or more jurisdictions depending on theelement, step, signal, perspective or advantage enabled. In addition,appropriate data use and other security authorizations or measures arefully contemplated, and may be relevant to judging the utilization andscope of challenges successfully overcome by this invention.

Using this invention, the patient, and optionally the patient's friends,family, and others, become active participants in the management and/orprogression of the patient's health. This enables the patient to beempowered as a collaborator through the system's patient portal, wherehe or she can access individualized educational, monitoring andself-care programs at any time from virtually any location. Although adeep and rich variety of data is acquirable, data having the mostrelevance for the specific patient may be designated for sensing, e.g. apatient's monitored signals may include intracardiac pressures, heartrate, physical activity, or other signals having the most utility forthe patient. This process of continuous data collection is thensupplemented by the uploads of all or some of the data to an externalproximate device (i.e. in home, office or car) for transmission of thecritical physiologic data securely to a healthcare management network.Physicians or others can access the network via a Web site at any timeand review screens that present summary information from the latestupload, trend information accumulated over time, and/or detailed recordsfrom specified times or problem episodes.

The invention has the potential to dramatically transform the managementof chronic diseases like heart failure and cardiac arrhythmias,neurologic conditions, or conditions requiring drug infusions, and otherhealth needs relating to particularly long-term health conditions. Itwill improve the quality of care by providing the physicians withreal-time data about their patients' physiological (and maybe other)conditions so that corrective actions may be taken in a timely manner,if appropriate. This invention will improve the quality of life for thepatients, enabling them to remain in their homes or travel as desiredwithout the same level of constant worry concerning an emergencyhospitalization. The invention will result in dramatic lowering of thecost of managing chronic disease by reducing unnecessaryhospitalizations and clinic visits. Perhaps more importantly, thissystem and methodology will help restore the close bond of thepatient-physician relationship through the power of direct connectednessand the proliferation of high relevance understandable knowledge to allparticipants in the process. For example, the system and methodologymakes personalized health information, even detailed information on theperformance of a patient's own heart, available to the patient and lovedones (or other advocates of the patient) through an interactive web ormobile portal. Other users of patients' data are now fully enabled toutilize this data for individual patient and systemic healthcareimprovements, as authorized. Analyses of this system have alreadyobserved many of these very positive effects, synergies and impacts.

In addition to the profound implications for quality of care, standardof care, and related issues in relation to this invention, the financialand business impact of this system and methodology is quiterevolutionary. The system is designed to more successfully manage peoplewith chronic diseases by leveraging the Internet or similarcommunication medium that allows continuous or near continuous real-timedata access. The interaction with clinical researchers of users of thisinvention is also valuable. This degree of interaction allows for morerapid and in-depth clinical analysis of disease symptoms and treatments,thereby reducing the overall costs of such efforts. Such real-timeaccess to patient data also facilitates administration of drug and othertherapy in a more responsive and economical fashion. The involvement ofthe patient and the patient's advocate(s) promotes improvedcommunication and outcomes. Combining this with the known patient desirefor greater convenience and a closer connection to the physician, thenthe advantages of this invention are many.

FIG. 2 is a schematic representation of a portion of system 50 designedfor interacting and managing care for a patient 16 having at least oneinteractive medical device, such as for example an implanted cardiac,neurologic, infusion or other device. It is recognized that partiallyimplanted or external devices may also be incorporated into the fullscope of this disclosure, provided such devices or components arecapable of operating in the robust data environment of this invention.FIG. 2 illustrates the relation between patient 16, an electronicallyaccessible patient management database 63, and a web-based site 70.Patient management database 63 is configured for receipt, storage,processing, and other transmission and handling of information relatedto the healthcare status of patients administered by system 50,including patient 16. Physiologic data 77 is uploaded via wireless 82 orother transmission means from devices in or in communication withdevices in or on patient 16, and is of a content and format designed toselectively provide essential high relevance information regarding allmanner of monitored disease etiology and system functionality. Thisinformation is automatically uploaded via path 82 to the database 63,possibly in response to interrogation routines, and subject to powermanagement, disease stage, and other considerations. Data 77 is thenregistered or otherwise processed as appropriate and transmitted invarious form to at least one web-based site 70, configured to allowaccess by the patient and others, as will be further discussed below,and as depicted in path 94 with one or more secure sign-in protocolsincluded. It is recognized that patient medical device data 88 may alsoflow from web-based site 70 back to patient management database 63.

FIG. 3 depicts web-based or equivalent site 70 as a platform which isaccessible via secure sign-in 101 by a first medical provider 106 suchas a nurse or other type of provider responsible for the care and firststage monitoring of patient 16. A variety of interactions are enabled bythis relationship, including use of web-based site 70 as a destinationfor secure access to provide and receive information pertinent to thecare of patient 16, including unique and high relevance physiologic data77 detected from within one or more patients and transmitted via patientmanagement database 63. In the event of physiologic data 77 containinginformation meeting certain criteria, such as activating triggers or setpoints based upon certain analytics, differentials or algorithmicmetrics, then the patient management database 63 and the web-based site70 may be configured to provide an automatic event notification servicesignal 112 to a display or other data receiving device of one or moremedical providers, such a first medical provider 106. In one example,automatic event notification service signal 112 may be pushed via anSMTP.net message, shown for example as signal format 115, to medicalprovider 106 computer or other display. These displays, and otherscontemplated herein, may also include an automatic pushed signal viaelectronic mail, pager, cellular phone, WAP cellular phone, telephonecall, facsimile, mobile wireless device, stylus tablet, or others. Thisautomatic event notification service signal 112 may be used to alertprovider 106 of a health related signal anomaly or other indicationwhich may require prompt action to assist the patient, and is likely notnecessarily a secure message but rather a rapid message, which may bemore preferable. Accordingly, in one embodiment, the rapid automaticevent notification service signal 112 includes a link accessible by themedical provider to rapidly access the data of interest from theweb-site 70, and which requires a response by the recipient. Such signal112, and others herein, may also activate an automatic time notatedarchival feature for later reference for various purposes. As in much ofthis invention, this path may require a security validation orauthentication, depending on system, patient service, and legalrequirements. Various biometric or other cipher-like technologies may beutilized, although a smart card or other intelligent and convenient toolmay be preferred. For example, one embodiment of a smart card may beable to record medical updates of the patient's health record wheneverit is used for access authentication, and thus provide an element ofredundancy to the medical record.

First medical provider 106, or others described herein, may be grantedsecure single sign in rights to facilitate rapid access for thedesignated individual to the various elements of this system andarchitecture. This feature may also be transportable as thatprofessional traverses among electronic links in order to ensureconnectivity during the response to a detected event, or the access maybe a graded access according to an event severity algorithm or othergrading technique.

A further feature may include a link or other access to a database 118or other medium having an electronic medical health record 122 of thepatient who is the source of the automatic event notification servicesignal 112. In this manner the patient's pertinent medical history maybe presented along with the new data which caused the medical alert,thereby allowing the medical provider to have proper perspective andaccuracy as to the specific patient. In one embodiment, electronicmedical health record 122 is a data rich format such as that known asExtended Markup Language (XML), although various data formats may beutilized to provide the advantages and data contemplated. Moreover, inone embodiment, a single page format is preferred but not required, inorder to allow the efficiencies of a template that may be efficientlystructured for a single screen display of the most critical informationto a final decision maker. This may include a summary, a waveform, adifferential diagnosis analysis, coding options, trending graphs,overlays of patient history versus current data, or other high relevanceformatted data appropriate to that patient or patient class. Rapidaugmenting/updating of that formatted information is also possible, whendesired, due to the configuration of this system and the rich datamining capabilities it enables.

FIG. 4 illustrates a further aspect of the invention in which a secondmedical provider 135 receives either the automatic event notificationservice signal 112 or, preferably, another form of notification signal144 which has been generated by another medical provider, such as firstmedical provider 106. Notification signal 144 is shown as a post-triagetype of notification, i.e. after the initial analysis of the highrelevance physiologic data has occurred by a first medical provider. Thesecond medical provider may be a more specialized or more highlyqualified provider, such as a cardiologist, surgeon or other type ofphysician. In one embodiment, notification signal may includerecommendations or commentary from the first medical provider, and maybe in the form of a secure asynchronous XML message, although variousformats may be acceptable or preferred, including for example thatnecessary to enable the above described single page formattedcommunication. The notification signal 144 may also be formatted fordisplay on a mobile or stationary device of medical provider 135, suchas a handheld or other form of personal digital assist device. In thismanner, even if the second medical provider is in the process of anotheractivity, it may be possible to have the information observed orotherwise understood from the display and for the second medicalprovider 135 to direct appropriate medical care in the form ofinstructions to the patient and other care givers. In one embodiment itis contemplated for the second medical provider 135 to observe theemergent conditions of patient 16 and then dictate a secure voicemessage 152 (for example, a WAV file attachment or the like) fortransmission back to a web-enabled site, such as web-site 70, for mergerwith the original data and automatic event notification service signal112 for subsequent transmission to the patient 16. Of course, thisinformation in the form of a combined signal of both the patient'sphysiologic data and the medical provider's interpretation and carerecommendation may also be transmitted to a proxy or other patientadvocate 159, as well as to automatic clinic appointment schedulerprompting mechanisms or the like.

Notification of patient 16 that a health-related message is waiting forreview may also be sent to the patient advocate 159, such as a closerelative of the patient, to ensure that the patient reviews,understands, and complies with the advice of the medical provider(s).This may be a sequence such as receipt of an electronic mail messageurging activation of a link to the web-site 70 with automatic routing tomessage 152. In addition to the various communication options notedherein above, it is possible to have a dedicated channel, optionalpop-up alert channel, webTV-like device, or dedicated internet serviceor portal available to the patient or patient advocate. This may be aservice provided by existing or new communication service providers as afee subscription or other revenue generating mechanism which is able toemerge and possibly block other communications until cleared by therecipient.

FIG. 5 is a high level logic flow chart representative of one embodimentof the computer implemented steps of the invention and the flow ofinformation. It is recognized that alternate flow paths may beimplemented within the scope of this invention while still achieving thenovelty, inventiveness, and technical contribution that the inventorsare merited. Step 193 represents the detect and store features of themedical device that is monitoring the patient or user of the device.Step 197 represents the interrogate function to query and receivephysiologic data from the medical device which is likely implantedwithin a patient. It is recognized that this function step may beobviated for a device which is external in view of different powermanagement options. Step 203 represents the transmission of data to aremotely located patient management database 210 for storage andprocessing of the received physiologic data. Step 217 represents theanalysis and set point computation steps necessary to determine whetherthe data received comprises particularly high relevance data thatnecessitates an alert. If an alert is not warranted then at step 219 thedata is routed to a web site for instantaneous presentation uponauthorized access by either the patient, a proxy or a healthcareprofessional. If an alert is warranted, then at step 221 a formattingprocess is implemented, and at step 225 a signal is sent to web-site 231notification routine causing a non-secure alert signal 240 to betransmitted in a push fashion according to pre-set protocol tohealthcare providers. These providers in turn query the web site byrapid return link activation 248 in either a secure or non-secure mannerwhich permits transfer of content rich rendered and formatted signal 256to the healthcare providers via the web site, and with the signalcomprising the high relevance physiologic data necessary for rapidanalysis and comment/action by the healthcare providers, leading totransfer to the patient and proxy 264 again via the web site at step 267with such comment/action recommendations riding thereon.

FIG. 6 discloses another embodiment of the invention in which patient350 is shown in a home setting and having one or more of an implantedmedical device 14. These devices may include pacemakers, defibrillators,neurological devices, drug pumps, implantable monitors, or any othertype of device which can act as a source of physiologic and medicaldevice data that can be suitably transferred from the device out of thebody. Where there exists a plurality of devices associated with onepatient,

-   -   the devices may also communicate between one another. The data        communicated can be of several types. It may be data about the        status of the device itself, such as battery status,        programmable parameters, or device performance. It may be data        which is sensed by the device such as electrical data or other        data from specialized sensors. The transmitted data may also be        processed or refined data such as prediction of an upcoming        event.

Transmission 360 signifies transmission of data from the implanteddevice 14 to external remote monitoring instrument 44. This may be asingle or a multi-step process. For example, in a single-step process,data is transmitted directly from the implanted device into a monitorwhich is connected to a communication system such as a telephone 365,which is only shown in representative rather than mandatory fashion. Ina multi-step process, the implanted device transmits data to anintermediate device such as a transponder which then subsequently sendsthe data to a device connected to a communication system. Any portion ofthis system could either be hardwired or wireless. The wireless systemcould use any type of wireless technology, including but not limited toradio frequency or infrared communication. In addition, any portion ofthe system could also do additional data synthesis or processing eitherfor compression, prediction, correlation, or any other reason for dataanalysis. In addition, the remote monitor could capture data fromsources other than the implanted device such as other externalinstrumentation, or any other source of data in that environment, ifdesired. The connections to these other data sources could be eitherhardwired or wireless. The data could be combined in the remote monitor,processed, or transmitted separately.

It should be recognized that server 405 represents a networked computingsystem which may consist of additional hardware and software includingdatabases, operating systems, communications channels, and all othernecessary components required to receive large volumes of data fromlarge numbers of users around the world and to be able to store, refine,analyze, and retransmit data. The communications network employed couldbe either private networks, virtual private networks, or public networkslike the internet. It is to be understood that the server may also beconnected to other computers on either private or public networks andthe implanted device data could be aggregated or otherwise combined withother data or services in the server.

Accordingly one embodiment of the invention is a system or method ofservice or alternatively a business method by which is provided a systemfor automatic implementation of a chronic remote patient monitoringservice. The service transmits high relevance data of a medical andphysiologic type from a patient having at least one implanted and/orwearable device. The system to provide this service product 471comprises a server 405 hosting medical and physiological data accessiblevia a remote monitor in data communications with the server. At leastone medical device 14 is implanted in a patient 350 or wearably locatedon a patient being in data communication with the remote server, and theserver is web-enabled to host and provide multi-directional datacollections from various services including the patient. In oneembodiment the at least one implanted and/or wearable medical device isin wireless communication with the remote monitor to enable datacommunications when the patient is ambulatory. The service provided alsoincludes programmable parameters to bill the patient, or others, for theservices provided.

FIG. 6 further illustrates data 479 flowing from server 405 to aphysician 483 or other clinician such as a paraprofessional or nurse whowishes to view the implanted device data or any of the other aggregateddata available on the server. As discussed herein above, the physicianor other clinician would have a password (or other access control) whichwould grant access to the specific data, and access could be grantedeither by the patient or by other appropriate authentication authority.The data 479 could flow from server 405 to the physician through avariety of means, including private or public networks such as theInternet. To maintain security, the server is presumably protected by avariety of security mechanisms such as a firewall or other mechanismswhich control access. If the data moves over a public network like theInternet, it is anticipated that the data would be encrypted. It is alsoanticipated that other services may be provided along with the data tothe physician, such as scheduling services, updates in medicalinformation, or any of a large variety of physician office services. Inreturn for access to this high relevance data 479 and/or the services,it is possible that the physician or clinician or clinic employing thephysician or clinician would pay a fee for the data or services. Any ofa number of billing and collection mechanisms can be envisioned for thisfee. The fee could be single use; that is, fee for each data view, or afee for each service used. Alternatively, the fee could cover a giventime period such as a monthly access charge or the like. The servicescould be versioned in multiple versions ranging in complexity andrichness and correspondingly having different prices. The billing andcollections process could be done in any number of ways, includingdirect computer-to-computer transaction, monthly statements, directcredit card transfer, or any other mechanism commonly used forbusiness-to-business billing and collection transactions.

Accordingly, a valuable service is enabled by use of the inventivefull-cycle information system by which the system is network-enabled toimplement a chronic data management and monitoring service for remotepatients and medical devices. The system includes: a server computersuch as that shown and represented by server 405 which is configured forhosting data transmitted from the remote patients and medical devices; aclient computer providing access to a plurality of users of the servicesuch as, for example, clinician-based computer 483. In this manner, andwith the stream of high relevance patient and service data available,the server computer provides a user interface whereby the plurality ofusers are authenticated prior to accessing the data, and the service isavailable via one of a secure web-based channels to enable anauthenticated user to access data pertaining to a specific patientand/or medical service. Various billing and collection systems may beemployed with this system, including, for example, services by which areutilized computer to computer transactions, monthly statements, directcredit or debit card/account transfers, micro-payment-systems andbusiness-to-business systems. It may be possible for query-generatedservice revenue to be integrated as well, for example, responsive tovarious user inquiries as discussed herein.

FIG. 6 further demonstrates an information network 510 within ahealthcare system. The healthcare system may be a clinic, amulti-specialty clinic, a hospital, a hospital system, or an integrateddelivery network of multiple hospitals, clinics, and outpatientfacilities. Healthcare system information network 510 typically collectsdata from multiple sites within the healthcare system such as, but notlimited to, radiology results 519, clinical laboratory results 526, orpathology results 530. Typically, physicians or other clinicians workingwithin the healthcare system have access to this information network asshown by arrow 538 between the physician 483 and the healthcare systeminformation network 510. This highly interactive system is a valuableservice product which enables implementation of high relevancephysiologic data transfer and exchange. This alone as a real-time,virtual real-time, or “archived” retrieval service is a product ofconsiderable importance and value, particularly when combined with thehigh relevance source data that is coming from the patient's device(s),and which may be further formatted or otherwise rendered as discussedherein.

Accordingly an internet based information network service forimplementing medical data transfer and exchange in a health care systemis provided. This service comprises means for collecting the medicaldata from multiple remote sites; and interference means for accessingsaid means for said collecting by authorized agents. Interface meansincludes controls for authenticating a user for the service and providesselection criteria and display at any one of said multiple remote sitesfor the user. It is anticipated that this service will providesubstantial value to the users and is therefore subject to optionalpayment systems as disclosed herein elsewhere.

FIG. 6 shows a further example of this unique data flow system andmethods of applying knowledge enhanced value to high relevance data. Thefigure further demonstrates data or other services flowing from server405 to healthcare system information network 510. It is envisioned thathealthcare systems will import data from the server to integrate withthe other clinical data on that patient within their respectivehealthcare system information network 510. FIG. 6 shows arrow 552between server 405 and healthcare system information network 510,signifying both a data/service path and a fee being charged for thehealthcare system information network to have access to the data andservices on the server. The data on the server represents importantinformation about the status of patient 350 or of the device 14 andwould be valuable to be integrated with other clinical data about thepatient who is followed within that healthcare system. The healthcaresystem can provide either more effective or efficient care by havingdata available from the server. For example, it is less expensive forthe healthcare system to check the status of an implanted device byhaving the data transferred from a patient's home than to have thepatient come to the healthcare system and use a clinic appointment tohave the data interrogated. The value that is created through this moreefficient device follow up mechanism is one basis of such a fee.Alternatively, the data may indicate that the patient is deterioratingand it becomes less expensive to anticipate this deterioration and treatit while the patient is at home than to wait for the patient to getsicker and come into the healthcare system. Similarly, this additionalvalue may become the basis for a fee. In either event, the healthcaresystem has an economic and performance incentive to pay a fee to haveaccess to the high relevance data on the server. As in the case of thephysician or clinician, any of a variety of billing and paymentmechanisms can be envisioned. A fee could be charged for each time theserver is accessed. That could be weekly, monthly or yearly accesscharges. There could be various versions of access differing inrichness, depth, or quantity of information presented or transferred.There could be a variety of billing or collection mechanisms, includingdirect computer-to-computer transfer, billings statements, or any of avariety of other mechanisms.

Accordingly, a system for implementing computerized health careinformation services is provided. This system is a network capable ofcollecting medical data from various remote locations including apatient with a medical device. The information service comprises aserver hosting medical and physiological data collected from a patientat a remote location, with the server being in data communications witha remote monitor that collects the data from the patient having at leastone implanted and/or externally worn medical device. A physician'sstation is provided, and a health care system information network indata communications with the server and the physician's station is alsoprovided. A billing service for the remote management of the patient'shealth, including a service of the performance of at least one implantedand/or externally worn medical devices, also provides communicating withthe physician's station for expert opinion and advising the patient inreal-time, and to advise as to proper procedures to follow for therapyand medical care.

FIG. 6 further shows a disease management organization 611 operating inassociation with a clinician 483 and a healthcare system 510. Diseasemanagement organizations typically undertake the responsibility ofmanaging a patient's disease in its entirety and may be contacted usinga variety of mechanisms such as yearly fees, risk sharing, orcaptivated/capitated payment. A disease management organization caneither exist as part of a healthcare system or may be outsourced.Disease management organizations typically exist to manage patients withchronic diseases such as heart failure, diabetes, asthma, arthritis, andcancer, although any disease could possibly be managed by a diseasemanagement organization.

It is recognized that disease management organizations typically attemptto capture and synthesize a variety of types of information. The figuredemonstrates information coming from clinical guidelines 621, data frompoint of care instrumentation 629, and data from patient interactions633, but many types of information are used by disease managementorganizations to manage a patient that are in addition to those shownfor example. Arrow 648 between the disease management organization 611and the healthcare system information network 510 represents that thedisease management organization may use data and services in thehealthcare system information network 510 and may also source dataand/or services to the healthcare system information network.

Once again, FIG. 6 also demonstrates how data and/or services may flowfrom the server 405 to the disease management organization 611. The data650 flowing from a server 405 becomes another source of informationwhich is used by the disease management organization to manage thepatient or function more effectively as an organization. Similar to thecase for the healthcare system, it is envisioned that the data and/orservices that can be supplied by the server will allow the diseasemanagement organization to treat the patient either more efficiently ormore effectively, saving money and improving care in either case. Inreturn for the data, the disease management organization pays a fee tohave access to the data/services. All of the comments about billing andpayment mechanisms discussed in the healthcare system and clinician casealso apply to the disease management organization. In addition, variouspayments structures can also be envisioned based on the way that thedisease management organization contract is written, includingsubscription fees, risk sharing, or captivated/capitated fees.

What is provided, therefore, is a system for implementing a diseasemanagement service in which a remote chronic patient with an implantablemedical device and/or wearable device(s) is provided. The serviceincludes multiple users of data and information exchange systemscooperating to provide the service for continuously managing the chronicpatient's disease in a highly efficient and value-added manner. In oneembodiment, the system comprises: a server hosting medical andphysiological data collected from the patient; a physician's station anddata communications with the server; and a health care systeminformation network being in a bi-directional communication with thephysician's station and further having a data communication with theserver; and a disease management organization in bi-directionalcommunications with the health care system information network. Theserver includes at least one set of databases of information concerningthe patient, so that the database is structured to assist the diseasemanagement organization in the management of the patient. In addition tothe basic data, as discussed herein, particular formats and rendering ofthe data is also available for a fee based access in order to improvethe utility of the high relevance data to the disease managementorganization.

FIG. 6 further shows data and/or services 702 flowing from server 405 toa medical device provider/manufacturer 715 (such as Assignee of theinvention, Medtronic, Inc.) and/or medical product/service provider. Itis envisioned that the data on the server could be used by medicaldevice manufacturer 715 in a variety of valuable ways.

A first embodiment shows the data 702 flowing to a research anddevelopment department 719. It is anticipated that having access tolarge and highly relevant databases of patient physiology and deviceperformance, will be a valuable source of information in the design ofnew devices.

A second embodiment shows the data 702 flowing to the product planningdepartment 729. Knowing how devices are programmed, device longevity,and potential failure modes will be usefully in planning new featuresand new devices. This is information which is very valuable andavailable from data 702.

A third embodiment shows the data 702 flowing to the departmentresponsible for post market surveillance 739. Many governmentalentities, e.g., countries, require manufacturers to perform post-marketsurveillance on their medical devices to understand device performanceand failure modes and mechanisms. Having this data available through theserver 405 will allow more accurate, timely, and complete informationcapture; all of which is highly valuable. Indeed, for this and otheruses, the particularly high volume of highly relevant data in a fullcycle system distinguishes this invention from others.

A fourth embodiment illustrates the data 702 flowing to a sales andmarketing department 749. The server data can help to evaluate whetherthe implanted device is appropriate for the patient's condition. Forexample, if the patient has an implanted ventricular defibrillator thatdoes not have any atrial fibrillation therapy modalities, and the datademonstrates that the patient is having episodes of atrial fibrillation,the sales and marketing department could contact the physician toreplace the implanted device with a different device that is moreeffective in treating all of the patients' conditions. This offers theopportunity for cross-selling or up-selling, particularly at the time ofdevice replacement, and is a very good example of the knowledge enhancedvalue of data/services represented as data 702.

A fifth embodiment demonstrates the data 702 flowing to clinicaldatabases 759. These clinical databases are envisioned to be largecollections of data captured from patients who send data to the serverand are maintained longitudinally over time. It is envisioned that thesecould be very large databases involving tens or hundreds of thousands ofpatients who are being followed for long durations, including possibly,years. These databases would offer information which is simply unmatchedand unattainable in any other way involving device performance andpatient physiology on very large numbers of patients over prolongedperiods of time. Using any of a variety of data mining mechanisms, someof which may be known in the art, it is anticipated that new patternsand new knowledge can be gained through the analysis and synthesis ofthese novel databases. For example, it is anticipated that deviceperformance, failure modes, and longevity will be able to be estimatedand predicted with far better accuracy than is possible today. Inaddition, it is anticipated that evaluating patient physiology willallow patterns of disease and prediction of future disease, rate ofonset, or disease progression which are not currently possible withoutthis invention.

FIG. 6 also illustrates selling or sharing the results of this datamining from the clinical databases 759 (or other sub-groups of entity715) to a disease management organization 611, as shown by arrow 778.Disease management organizations need to understand disease progressionand cost structures in order to be able to profitably run theirbusiness. Such organizations must estimate the costs that they willincur in taking care of patients when they contract with a healthcaresystem. Better information that allows more accurate prediction of costsis highly valuable to these organizations. In return for this betterpredictive information which is a result of the data mining of the highrelevance clinical databases, the disease management organization pays afee. This fee could be structured in any of a variety of ways. Forexample, the disease management organization may want data only on itsown enrolled patients which are contained in the clinical database andwould pay either a subscription or access fee to be able to estimatecosts of their enrolled population. Alternatively, disease managementorganization 611 may be interested in population behavior that wouldallow it to better estimate future costs. In this case, the fee couldtake the form of intermittent updates, fees for algorithms, fees foranalyst's reports, or any of a variety of data product or data-servicerelated mechanisms. Any one of a number of billing and collectionmechanisms could be utilized including direct computer-to-computertransfer, standard invoicing and payments, or any other mechanism forbilling and collection.

In similar fashion to that above, data and/or data-products and/ordata-services from the clinical database (or other sub-group of entity715) flow to the healthcare system information network 510 via arrow788. In similar ways as those described for disease managementorganizations, healthcare systems need to be able to predict andanticipate operating costs, utilization, quality, and other operatingmetrics. The information which is synthesized through the data mining ofthe large clinical databases can be a source of extremely valuableinformation to healthcare systems. For example, a healthcare systemcould compare device failure or malfunction rates within its healthcaresystem to population statistics to determine quality of deviceimplantation and follow up. Alternatively, a healthcare system couldcompare the physiology or complications from its patients to populationstatistics. Healthcare systems could predict utilization of theirservices by evaluating complication rates within large populations ofpatients and extrapolating that data to their own population. Many othervaluable types of information can be envisioned, and particularly whenusing high relevance and rapidly accessible high volume data/informationwhich is nowhere else found. In return for this exceptionally uniqueinformation, the healthcare system would pay a fee to entity 715. Thesefees could be structured in a variety of ways depending on the type ofinformation, frequency of interaction and depth of richness and utilityof information. Potential mechanisms include time based subscriptions,single use access fees, and multiple versions. Invoicing, billing andpayment could be carried out as well through a variety of mechanisms,including direct computer-to-computer transfer, credit card billing,paper invoicing and checks, or any of the multitude of ways of billingand collecting in business.

This example shows an information system for generating medical deviceperformance data, in real-time, to enhance product performance and adaptbusiness methods to provide a continuously improving service to achronic patient. The information system comprises a server hosting datatransmitted from a remote patient; a plurality of client computersproviding access to the server; and a medical device related entitycomputer being in data communications with the server wherein devicedata is managed to provide at least a certain quantity of informationderived from a sub-group of the medical device entity, for use byengineering personnel and others in disease management organizations orhealth care systems.

FIG. 6 further illustrates relationships and inventive methods ofperforming tasks and of doing business involving patients, consumers,and others using interrogated high relevance implanted device data onthe internet or web-enabled system 802. This figure shows data beingtransferred from the server 405 to an internet website 807 which is acustomized website, similar to that earlier described in relation toweb-based site 70 of FIGS. 2-4. Site 807 is representative of aplurality of various sites which could be used in this application. Thistransfer could involve raw data or synthesized or refined data, and isrepresented by arrow 815. The transfer of this data could either occurcontinuously or intermittently depending on the application. The data,or refined, synthesized, or analyzed data/signals could either reside onthe website 807 or the website could use the server as a source of datawhen queried by the user.

A user may access website 807 and view the data supplied by the server.This creates a complete loop of high relevance, fresh informationstarting with the patient (or other entity) interrogating the implanteddevice 14 with data flowing through the remote monitor, through acommunications channel such as a telephone or other means, to a server405 (or element functioning as such), to a website 807 and subsequentlyback to the patient, as shown via data/services arrow 825. This closedloop can serve as a system by which the patient changes something inthis environment based on the information supplied by the interrogateddevice.

For example, the patient may change a dose of medicine, alter theirlifestyle, or diet, or any other aspect of his/her medical care based onthe updated information which is supplied through website 807. It isanticipated that this website will display the most recent data alongwith a longitudinal record of the patient's data in the past. Inaddition, the patient's individual data may be compared to populationstatistics which are available on the server which would allow thepatient to compare his particular medical condition to larger numbers ofpatients with similar problems. It is also anticipated that the patientwill interact with the website to supplement the data coming from theserver with additional user-entered information such as current drugregimens, quality of life information, lifestyle information, or anyother information which could be useful when stored on website 807 andaggregated with the implanted device data. This further informationseeking may also serve as a rating mechanism for rating the relevanceand value of the user's inquiries in relation to the observedphysiologic condition. This rating may then be a factor in furtheractions, including fee related actions.

It is contemplated that the user (whether patient or another user) willpay a fee for the services available on website 807. This fee mighttypically take the form of a monthly subscription fee to allow the userto access the website and the personal data residing at that site. Anyof the methods used to bill and collect payment on internet sites suchas credit card billing or direct billing could be used. It is alsocontemplated to provide multiple versions of the service available,including basic versions which may be lower priced or even rangingthrough richer and deeper applications and service offerings which willbe priced accordingly. The financial transactions may be done usingencrypted data transmissions as is common on public computer networksuch as the Internet: The data transmission and medical informationtransmission can either be done using encryption or might also be donein a non-encrypted format.

It is also anticipated that the patient will be able to designate otherusers who can log on to the patient's account on website 807 to view thepatient's specific data and information. These users might includefamily members, homecare givers, friends, advocates or any other personthat the patient designates such as in a “friends and family” list. Itis also anticipated that any one of the friends or family could also payfor the patient's account by billing a member of the “friends andfamily” list rather than the patient himself. In addition, it ispossible that there would be access charges for the designated userswhich could range from single transaction fees through monthlysubscription fees. Alternatively, charges might be adjusted according tohealth plan providers in view of the positive economic impact to ahealth care system when a patient and/or patient's friends or family areactively involved in the patient care or monitoring. It is alsoimportant to note that the hardware or software components of the systemwhich are required in the closed loop could be bundled with the onlineservice charges. For example, the remote interrogation device, might bepurchased directly by any one of the potential users of the system, suchas the patient, the physician, the healthcare system, the diseasemanagement organization, or a friend or family member. Alternatively,the cost of the remote monitor could be included as part of the internetservice fee charged or accessed on website 807 in return for asubscription of minimum length such as two or three years. Additionally,software upgrades either to the remote monitor or the website could bepurchased directly by any of the users of the system or also could bebundled within the overall Internet service offering. Again, althoughnot envisioned as the primary way of charging for this service, it ispossible that either the healthcare system, disease managementorganization, or other healthcare entity may elect to pay for theInternet service for the patient to ensure that the patient has thisservice that ultimately will be of benefit to that healthcare entity. Aswill be further discussed, website 807 is also connected to other healthsites who may extract value by having patients have the customizedwebsite 807 service offering. It is conceivable as well that one or moreof these other websites could pay the access fee for the patient to sucha website 807.

FIG. 6 also shows links between website 807 and other Internet healthsites. There are currently many health sites on the Internet with avariety of information, service, and revenue models. Most of these sitesbenefit by having additional users log onto their sites. Website 807could structure business relationships with these health sites wherebyusers on would become aware of pertinent or relevant content on otherhealth sites 820. If a user transfers from website 807 to that otherhealth site, the other health site would pay a fee to website 807 fordelivering a user to their site. This communication and fee structure isshown, for example, by arrow 825.

This figure also illustrates the connection between website 807 and thewebsites of pharmaceutical companies 831 on the internet. It isanticipated that website 807 may contract with pharmaceutical companiesto make information about their products available to users of website807. If a user moves to the website of a pharmaceutical company or usesthe services of a pharmaceutical company, it is anticipated that companywould pay a fee to the owner at website 807, indicated by data andrevenue arrow 835. Several different fee structures can be envisioned.For delivering a patient to a pharmaceutical site, a “click through” feecould be generated. If the patient purchases additional services on thepharmaceutical site, a fee which could represent a percentage of revenueor an additional one time fee could also be generated. For example, if auser ends up getting a prescription for a drug through their interactionwith the pharmaceutical site, the pharmaceutical company could pay aportion of that revenue back to website 807. In addition, if the patientbecomes a user of other services which are offered by the pharmaceuticalcompany such as enrollment in a disease management program, then aportion of related or attributable revenues would also be returned towebsite 807. Additionally, patient data could flow to the pharmaceuticalcompany if permitted by the patient. The pharmaceutical company may haveinterest in evaluating patients responses to medications and the highrelevance data collected by the implanted device and offered at website807 may be valuable data to the pharmaceutical company. In this case, afee would be charged to the pharmaceutical company for the data. Thiscould either be one time access fees or fees for access to data overmore prolonged periods of time.

Also demonstrated is a connection between website 807 and a clinicaltrial organization 841 such as a contract research organization.Clinical trial organizations typically perform clinical trials formanufacturers of pharmaceuticals or devices. There are a number ofdifferent ways that internet based interaction could occur. Website 807could contract with a clinical trial organization to identify patientswho may set the criteria for clinical trial enrollment. If a user ofwebsite 807 meets the enrollment criteria, website 807 could inform thepatient that they could be eligible for a clinical trial and refer thepatient to the clinical trial organization for enrollment. This could bedone either by connecting them to the clinical trial organizationwebsite or through more traditional means such as a phone number or anoffice contact. The clinical trial organization would pay a fee forreferring the perspective enrollee. If the patient actually enrolled inthe clinical trial, one or more additional fee(s) could be generated.Another interaction is that data collected at website 807 could beuseful in the monitoring and management of the clinical trial. In returnfor the clinical trial organization having access to patient data atwebsite 807, which may make the clinical trial more effective,efficient, or faster, the clinical trial organization would pay a feefor data access. These fees and data-related products/services arerepresented by arrow 845.

FIG. 6 also shows the interaction between website 807 and variousretailers 851 on the internet. These may be retailers offering medicalequipment, but could also include retailers selling diverse items suchas books, exercise equipment, or virtually any item which may be ofinterest to the user of website 807. The operator of website 807 wouldcontract with various internet retailers to deliver patients to theirsites based on their interests and/or ratings as well as the data whichis acquired from the implanted device, all of which may be doneautomatically based on the patient's physiological data or othermechanisms. For example, if the data from the implanted device indicatedthat the patient was having episodes of a particular type of arrhythmia,the patient could be referred to a book retailer with specific books onthat arrhythmia. Fees would be generated through a variety ofmechanisms. The store would pay a fee for the referral of the patient tothe store website. If the patient actually accesses and/or purchasesitems at that online store, a percentage of the revenue would flow backto website 807. These data services/products and fees are designated byarrow 855.

The figure further demonstrates the interactions between website 807 andother major internet companies 861 such as major portals, searchengines, internet service providers, and the like. Many of thesecompanies generate revenue based on advertising, which depends on uservolume. Customized websites 807 could create arrangements with otherinternet companies to refer patients to those companies' websites ifthere is particularly relevant content or services available at thosesites. For example, based on the implanted device data, a patient may bereferred to a particular search engine which is particularly powerful insearching sites relating to that patient's particular problem. In returnfor the referral to the site, a fee is generated, as indicated by dataservices/products and fee arrow 865. In addition, if the patientsubsequently purchases additional services from that site as a result ofbeing routed to that site through website 807, a portion of review wouldbe returned to website 807.

Similar relationships may be possible with patient advocacy groups 871,having valuable charters or missions which can have considerabletangible and intangible value to healthcare services, products, anddecision makers. Such value may have a fee component, which is shownhere as data services/products and fee arrow 875.

Accordingly, a system for implementing a network remote patientmanagement services fee generating series of transactions comprises aserver hosting patient management data for providing chronic monitoringof remote patients with chronic disease having implantable medicaldevices and/or wearable devices. The system further comprises a serverbeing accessible via client computers wherein the client computersinclude a web-enabled system, a medical device entity website, aphysician or other clinician site, a healthcare information networksite, and a disease management organization. Each of the clientcomputers are in data communications with the server to import specificdata on which the patient management services billing schemes, for atleast one service, are implemented.

FIG. 7 illustrates a variation of a method of providing data productsand services, or alternatively methods of doing business, as describedhereinabove. This variation places or positions the (patients' implanteddevice) server 405 at the center of the patient information flow. FIG. 6shows, for example, most data flowing in one direction from server 405to various users, which are now shown in FIG. 7 as bi-directionalarrows.

This indicates that data could be flowing in both directions. Theimplanted data server 405, by being at the center of all of theseinformation flows, could act as an aggregator of data and become thecentral repository of data about this particular patient. For example,while interrogated device data could flow from the server 405 tointegrate what the healthcare systems information network 510 containsas other data on the patient, the data from the healthcare systeminformation network 510 could flow back to the server 405. Similarly,rather than data flowing only from the server 405 to the diseasemanagement organization, data could also flow backward from the diseasemanagement organization to server 405. With multiple information flowscoming to the server 405, it could become the central repository ofmultiple data sources. In return for this data access, the server 405might generate payments to the sources of data such as the healthcaresystem information network or the disease management organization oralternatively process the returned data as a product/service afterrevision algorithms or updated databases for a further fee from the dataproviders. Therefore, in the same way that the information flow arrowsare now two way, the revenue flow could also be bi-directional oroptionally remain one-way. Of course, by having an aggregated set of thepatient's data residing at the server, that data could then berepackaged with further knowledge enhanced value and resold to any of avariety of interested users beyond just the healthcare systems, diseasemanagement organizations, or integrated delivery systems, as may beagreed. Any of those organizations could also subsequently pay a fee foraccess to the integrated and aggregated data.

Accordingly, a personalized set of electronic web-based health andmobile health services may be provided and tailored to provide real-timeand uninterrupted chronic patient management for remote patients with amedical device. These services include a billing scheme which isautomatically implemented for services rendered, with the billing schemecomprising a server computer hosting the services accessible via clientcomputers to a plurality of potential users of the service; and with theclient computers being web-enabled to provide various service options tothe user. The services are available over the internet to assist aspecific user in locating and accessing a required service relating tothe patient.

The above described invention relates to a patient-focused service ofthe highest order in which one or more implantable medical devices areimplanted in a patient, and wherein the devices are adapted to connectthe patients with caregivers for an uninterrupted management of chronicdisease. Specifically, the invention also relates to a seamless flow ofinformation between a surgical suite where the devices are implanted,the availability of support/expert systems, and improved availability ofcaregivers to the patient's home.

As noted, the health care systems worldwide need to provide bettereconomic and lifestyle options for patients who suffer from chronicdisease. Further, there is a need to empower patients to respond totheir needs in a responsible way. Specifically, a system that enablespatients and physicians to better treat chronic disease through the useof a remote monitoring communication and therapeutic technologies, ishighly desired. More importantly, a total closed loop patient managementsystem as well as support entity improvement tools which enable acontinuous communication between patients, caregivers and physicians,will provide both patients and physicians with the knowledge that theyneed to make better treatment and organizational/resource managementdecisions.

Application of the invention(s) herein will move care beyond an episodicevent to managing care over the course of one's disease. For example, adisease management system that allows physicians to select moreappropriate treatment pathways in the management of chronic pain wouldrequire a bi-directional communication system between patients andremote physicians and caregivers. Specifically, as it relates to chronicdisease, a system that enables patients and caregivers to have anuninterrupted continuous communication between them, would assist in thedelivery of more effective and lower cost care for the patient.

The invention thus relates to multiple types of technologies integratedto support an infrastructure of networks for implanting a medicaldevice, managing the medical device operations and performance, andchronic monitoring of patients while allowing them to lead a normal lifeat home and away from the hospital.

The invention exploits a combination of traditional medical technologywith new advances in information and communication technology, coupledwith the biologic sciences to transform the practice of medicine. Morespecifically, the invention creates services that will connect patientswith their caregivers. This connectivity will allow connectivity tomanage and especially enhance the flow of information between caregiversand patients, in order to provide the knowledge necessary to makeinformed decisions about the patient's health care over an extendedperiod of time.

Another example of the integrated approach of the present invention isfurther illustrated as, optionally, starting in the Network OperatingRoom 962 (shown schematically in FIG. 8) where a clinical knowledgedelivery system provides the physician with up-to-date information onthe device to be implanted in the prospective patient. Specifically, thephysician will be provided with complete care knowledge delivered in anenvironment that not only meets, but also anticipates, the surgicalteam's every requirement. The Network Operating Room 962 can, forexample, bring a clinical specialist directly into the operating roomthrough a virtual clinical support system.

It is anticipated that the specialist could be one who could offerin-depth product knowledge and has a deep understanding of a particularprocedure so that technical service and support could be given at theexact moment in surgery when it is required by the physician. Thenetwork operating room also contains a high speed information portal975, a conduit to deliver the patient's most relevant care informationsuch as knowledge-enhanced radiographs, physiologic monitoring andinformation of anatomic and functional displays. All this, and similarfunctions, would be under the physician's control. Video audio graphics,even highly realistic holographic imagery could be delivered where thephysician needs it, when she needs it.

Further, an on-line consultation with physicians 979 remotely locatedfrom the operating room, could be initiated using, for example, anexpert on-call program. As the on-call physician connects with theNetwork Operating Room, they are provided with a summary of the surgicalplan and reference similar procedures using, for example, vast clinicaldata repositories 982 via server 988. Accordingly, the inventionprovides complete connectivity between all care providers whoseinstantaneous availability anywhere in the world to cover all aspects ofcare, is available in the operating/emergency/procedures room. Further,a parallel network of support systems 993 provides the patient in thehome with connectivity to the primary care physician and other healthcare professionals via appropriate connectivity or communicationsinterfaces 995. Thus the service is focused entirely on the patient,improving the physical condition and psychological outlook of patients,and reducing the anxiety among patients and others involved inhealthcare.

The invention therefore provides a standards-based network forprocedural room support, chronic disease management and medical devicemanagement services that are accessible to enable patients andphysicians to effectively manage chronic disease through remotemonitoring, communication, and data exchange on a continuous basis. Thepresent invention provides virtual support systems to enable patients tolead a full life in spite of chronic disease, and appropriate revenuesavings and fee generation results so as to encourage utilization ofsuch a system. Connectivity may be via electronic, mobile lines 997 ofdata transfer, as disclosed in various embodiments herein.

This invention contemplates various systems and various types of methodsto enable substantial economic and medical improvements to the business,art and science of healthcare. It is believed that these innovations andtechnical contributions provide a powerful combination of features andservice advantages in view of the previously stated challenges toreal-time effective management of certain classes of patient, such asthose with chronic cardiac disease, constant infusion of medicines,neurologic stimulator requirements, or others, and that this has notbeen accomplished or realistically contemplated before by others.

1. An internet-based method for a paid service to maintain dataconnectivity of a remote medical device-configured patient to a databasenetwork and to enable medical device data exchange and processing,comprising the steps of: receiving in a substantially continuous mannerat a database network site first data inputs uniquely representative ofsensed physiologic information from a specific medical deviceconfiguration of a patient using said medical device configuration;enabling the database network site to communicate with at least oneweb-enabled web-site and to receive web-site originated signalsrequesting access to representations of said first data inputs from saiddatabase; and monitoring data packages to determine revenue for theservice.
 2. The service method of claim 1 further including the step ofproviding said web-site and configuring said web-site with a userinterface which includes a sign-in input to enable access to saiddatabase network site.
 3. The service method of claim 1 in which thereceiving step includes receiving at least one signal carryinginformation representing sensed physiologic status within the patientfrom at least one medical device located on or at least partially in thepatient's body.
 4. The service method of claim 1 in which the receivingstep includes receiving signals carrying information representing actualphysiologic phenomenon within the patient as sensed by at least onemedical device located on or at least partially in the patient's body.5. The service method of claim 1 in which the receiving step includesreceiving signals carrying information representing actual physiologicphenomenon within the patient as sensed by a plurality of medicaldevices located on or at least partially in the patient's body.
 6. Theservice method of claim 1 in which the enabling step comprises providinga secure sign-in and validating an originator's security-related actionprior to allowing access of the originator to the database information.7. The service method of claim 1 in which the first data inputs providesintermediate information to enable further production of datarepresentations enabling subsequent actions.
 8. An internet-based methodfor a paid service to maintain connection of a remote medical deviceconfigured patient to a database network and for medical device dataexchange and processing comprising the steps of: providing a web-site ina web-enabled system, the web-site having a user interface whichincludes a sign-in input to enable access to a database network siteassociated with said web-enabled system; receiving in a substantiallycontinuous manner at the database network site first data inputsuniquely representative of sensed physiologic information from aspecific medical device configuration of a patient using said medicaldevice configuration; receiving at the web-site second data inputsrequesting access to representations of said first data inputs availableat said database; and enabling the originator of said second data inputsto have access to the database via the secure web site to viewrepresentations of said first data inputs.
 9. The service method ofclaim 8 in which the database network site receiving step includesreceiving at least one signal carrying information representing sensedphysiologic status within the patient from at least one medical devicelocated on or at least partially in the patient's body.
 10. The servicemethod of claim 8 in which the database network site receiving stepincludes receiving signals carrying information representing actualphysiologic phenomenon within the patient as sensed by at least onemedical device located on or at least partially in the patient's body.11. The service method of claim 8 in which the database network sitereceiving step includes receiving signals carrying informationrepresenting actual physiologic phenomenon within the patient as sensedby a plurality of medical devices located on or at least partially inthe patient's body.
 12. The service method of claim 8 in which theenabling step comprises providing a secure sign-in and validating anoriginator's security-related action prior to allowing access of theoriginator to the database information.
 13. The service method of claim8 in which the first data inputs provides intermediate information toenable further production of data representations enabling subsequentactions.
 14. An internet-based method for a paid service to maintaindata connectivity of a remote medical device-configured patient to adatabase network and to enable medical device data exchange andprocessing, comprising the steps of: receiving in a substantiallycontinuous manner at a database network site first data inputs uniquelyrepresentative of sensed physiologic information from a specific medicaldevice configuration of a patient using said medical deviceconfiguration; initiating processing of said first data inputs toproduce user accessible signals which represent the first data inputs ina user accessible format to enable action based on observations of theuser accessible signals; and enabling the database network site tocommunicate with at least one web-enabled web-site and to receiveweb-site originated signals requesting access to representations of saidfirst data inputs from said database.
 15. The service method of claim 14in which the step of initiating processing includes initiating analysisof the first data inputs to determine whether any sensed physiologicactivity is abnormal.
 16. The service method of claim 14 in which thestep of initiating processing includes initiating analysis of the firstdata inputs to determine actual values for any sensed physiologicactivity.
 17. The service method of claim 14 in which the step ofinitiating processing includes initiating analysis of the first datainputs to determine whether any sensed physiologic activity isindicative of a demonstrable or likely pattern of physiologicalactivity.
 18. An internet-based method for a paid service to maintaindata connectivity of a remote medical device-configured patient to adatabase network and to enable rapid medical device data exchange andprocessing of certain conditions, comprising the steps of: receiving ina substantially continuous manner at a database network site first datainputs uniquely representative of sensed physiologic information from aspecific medical device configuration of a patient using said medicaldevice configuration; and enabling the database network site tocommunicate with at least one web-enabled web-site to automaticallydeliver representations of said first data inputs from said databasewhen certain conditions are met.
 19. The service method of claim 18 inwhich the step of enabling includes initiating automatic softwareanalysis of the first data inputs to determine whether any sensedphysiologic activity is abnormal.
 20. The service method of claim 18 inwhich the step of enabling includes initiating automatic softwareanalysis of the first data inputs to determine actual values for anysensed physiologic activity.
 21. The service method of claim 18 in whichthe step of enabling includes initiating automatic software analysis ofthe first data inputs to determine whether any sensed physiologicactivity is indicative of a demonstrable or likely pattern ofphysiological activity.
 22. A computer implemented method for improveddata management in the healthcare industry by increasing patientengagement with recommended healthcare delivery modalities, comprisingthe steps of: a. providing an implanted medical device configured forautomatic sensing of high relevance biologic data of the patient andtransmitting that data, or portions thereof, to an information parser ofthe healthcare professional; b. configuring a patient accessibleelectronic interface to receive signals representative of sensed highrelevance biological data of the patient; c. providing selectivelyprogrammable computer implemented rapid interpretations of the sensedhigh relevance biologic data and, when indicated, electronically sharingwith the healthcare professional the details of the sensed highrelevance biological data without resort to personal contact or face toface meeting between the healthcare professional and the patient; and d.providing information flow paths for the healthcare professional tofurther contribute to the knowledge database and patient engagement byoffering the patient and a patient's designated advocate directinformation about the high relevance biologic data thereby activelyengaging the patient in a highly content rich yet efficient manner. 23.A computer implemented internet-based method for an improved connect andmonitoring service to rapidly connect remote persons to a databasenetwork for medical device data exchange and analysis, said method beingcharacterized in that it comprises the steps of: providing a web-sitehaving a user interface wherein the user interface includes a securesign-in input to access a database network site; receiving at theweb-site automatic inputs associated with a specific medical device anduser of the device; automatically confirming the identity of the medicaldevice and the user; enabling the user to access the database via theweb-site to use the service for real time monitoring of high relevancephysiologic data mined from all monitored data of the user; and enablingthe database network site to communicate with at least one web-enabledweb-site and to receive web-site originated signals requesting access tothe database.
 24. The method of claim 23 wherein said web-site furtherincludes a proxy right access scheme to provide privileged access to auser's data by friends or family as programmed.
 25. A computerimplemented internet-based method for improved user compliance within amedical patient management system in which the system automaticallydetermines which connection protocols to follow to rapidly connect oneor more remote persons to a database network for medical device dataexchange and analysis under certain conditions, said method beingcharacterized in that it comprises the steps of: providing a web-sitehaving a user interface wherein the user interface includes a securesign-in input protocol to access a database network site; receiving atthe web-site automatic inputs associated with a specific medical deviceand user of the device; automatically confirming the identity of themedical device and the user; performing computer implemented analyses todetermine which user groups to rapidly and selectively automaticallyaccess the database via the web-site for receipt of high relevancephysiologic data mined from all monitored data of the user; and enablingthe database network site to communicate with at least one web-enabledweb-site and to receive web-site originated signals requesting access tothe database.
 26. The computer implemented internet-based method forimproved user compliance of claim 25 further comprising: alerting aselect group of medical providers to an event using an event service;and enabling the select group of medical providers to execute secureaccess to the device user's database in a single sign-on action per userin the group.
 27. The method of claim 26, wherein said single sign-onaction includes authentication to a foreign web-site that is passed overto access the secure device user's database.
 28. The method of claim 25further characterized by computer implemented automatic formatting ofautomatically processed high relevance data mined from all detecteddata, and electronically pushing the formatted data to an electronicdisplay of at least one member of a group of medical providers wherebyat least one of the group of medical providers selectively providescommentary and then directs a data transmission back via the web site tothe user of the medical device, to a designated advocate of the user ofthe medical device, and, optionally, to another member of a medicalproviders group.
 29. A computer implemented patient management networkconfigured for automatically determining which connection protocols tofollow to rapidly connect one or more remote persons to a databasenetwork for medical device data exchange and analysis, said networkbeing characterized in that it comprises: a web site having a userinterface wherein the user interface includes a secure sign-in inputprotocol to access a database network site; said web site providing foracceptance of automatic inputs to the web site associated with aspecific medical device and user of the device; processing routines andmodule for automatically confirming the identity of the medical deviceand the user; and processing routines and module for performing computerimplemented analyses to determine which user groups to rapidly andselectively automatically access the database via the web-site forreceipt of high relevance physiologic data mined from all monitored dataof the user. means for enabling the database network site to communicatewith at least one web-enabled web-site and to receive web-siteoriginated signals requesting access to the database.
 30. A system forimplementing a disease management service for a remote chronic patientwith an implantable medical device and/or wearable device wherein theservice includes multi-users of data and information exchange systemscooperating to provide the service for continuously managing the chronicpatient's disease, health care and medical devices comprising: a serverhosting medical and physiological data collected from the patient; aphysician station in data communications with the server; a health caresystem information network being in a bi-directional communication withthe physician station and further having a data communication with theserver; a disease management organization in bi-directionalcommunications with said health care system information network; saidserver including at least one set of database of information concerningthe patient wherein the database is structured to assist the diseasemanagement organization to manage the patient for a fee; and said serverincluding means for enabling the database to communicate with at leastone web-enabled web-site and to receive web-site originated signalsrequesting access to the database.
 31. A system for implementing adisease management service for a remote chronic patient with animplantable medical device and/or wearable device wherein the serviceincludes multi-users of data and information exchange systemscooperating to provide the service for continuously managing the chronicpatient's disease, health care and medical devices comprising: a serverhosting medical and physiological data collected from the patient; aphysician station in data communications with the server; a health caresystem information network being in a bi-directional communication withthe physician station and further having a data communication with theserver; a disease management organization in bi-directionalcommunications with said health care system information network; saidserver including at least one set of database of information concerningthe patient wherein the database is structured to assist the health caresystem information network to manage the patient for a fee; and saidserver including means for enabling the database to communicate with atleast one web-enabled web-site and to receive web-site originatedsignals requesting access to the database.
 32. A system for implementinga disease management service for a remote chronic patient with animplantable medical device and/or wearable device wherein the serviceincludes multi-users of data and information exchange systemscooperating to provide the service for continuously managing the chronicpatient's disease, health care and medical devices comprising: a serverhosting medical and physiological data collected from the patient; aphysician station in data communications with the server; a health caresystem information network being in a bi-directional communication withthe physician station and further having a data communication with theserver; said server including at least one set of database ofinformation concerning the patient wherein the database is structured toassist the health care system information network to manage the patientfor a fee; and said server including means for enabling the database tocommunicate with at least one web-enabled web-site and to receiveweb-site originated signals requesting access to the database.
 33. Asystem for implementing a disease management service for a remotechronic patient with an implantable medical device and/or wearabledevice wherein the service includes multi-users of data and informationexchange systems cooperating to provide the service for continuouslymanaging the chronic patient's disease, health care and medical devicescomprising: a server hosting medical and physiological data collectedfrom the patient; a physician station in data communications with theserver; a disease management organization in bi-directionalcommunications with said server and said physician station; said serverincluding at least one set of database of information concerning thepatient wherein the database is structured to assist the diseasemanagement organization to manage the patient for a fee; and said serverincluding means for enabling the database to communicate with at leastone web-enabled web-site and to receive web-site originated signalsrequesting access to the database.
 34. A data collection and transfersystem for implementing a chronic remote patient monitoring service fortransmission of very high relevance medical and physiological data froma person having at least one implanted and/or wearable medical device,the service comprising: a server hosting high relevance medical andphysiological data accessible via a remote monitor in datacommunications with the server; at least one medical device implanted orwearably located on a person being in data communication with the remotemonitor; the server being web-enabled to host and providemulti-directional data collections from various services including saidperson so that the collected data may be re-transmitted for a feeprovided by one or more recipients of the data; and the server includingmeans for enabling the database to communicate with at least oneweb-enabled web-site and to receive web-site originated signalsrequesting access to the database.
 35. The service of claim 34 whereinsaid at least one implanted and/or wearable medical device is inwireless communication with the remote monitor to enable datacommunications when the person is ambulatory.
 36. The service of claim34 wherein said server includes programmable parameters to bill theperson for services rendered.
 37. A system for implementing acomputerized healthcare information service network capable ofcollecting medical data from various remote locations including apatient with a medical device, the information service comprising: aserver including a database hosting medical and physiological datacollected from a patient at a remote location, said server being in datacommunications with a remote monitor that collects highly relevant datafrom the patient having at least one implanted and/or externally wornmedical device; the server including means for enabling the database tocommunicate with at least one web-enabled web-site and to receiveweb-site originated signals requesting access to the database; aphysician station; a health care system information network in datacommunications with the server and the physician station; and a billingservice for the remote management of the patient's health including aservice of the performance of at least one implanted and/or externallyworn medical device communicating with the physician station for expertopinion and advising the patient in real time, to provide as to properprocedures to follow for therapy and medical care.
 38. A network-enabledsystem for implementing a chronic data management and monitoring servicefor remote patients and medical devices comprising: a server computerhosting high relevance data transmitted from the remote patients andmedical devices; a client computer providing access to a plurality ofusers of the service; and wherein said server computer provides a userinterface whereby said plurality of users are authenticated prior toaccessing said data; whereby the service is available via one of asecure Internet channels to enable an authenticated user to access datapertaining to a specific patient and/or medical device.
 39. The serviceof claim 38 wherein said service utilizes billing and collection systemsconsisting of one of: computer to computer transactions, monthlystatements, direct credit card transfer, micro-payment-systems andbusiness to business collection systems.
 40. An internet-basedinformation network service for implementing medical data transfer andexchange in a health care system comprising: means for collectingmedical data from multiple remote sites including a database site; andinterface means for accessing said means for collecting by authorizedagents; wherein said interface means includes controls forauthenticating a user for the service and provides selection criteriaand display at any one of said multiple remote sites for the user; andmeans for enabling the database network site to communicate with atleast one web-enabled web-site and to receive web-site originatedsignals requesting access to the database.
 41. An information system forgenerating medical device performance data, in real time, to enhanceproduct performance and adapt businesses methods to provide acontinuously improving service to a chronic patient or other informationusers, the information system comprising: a server hosting datatransmitted from a remote patient; a plurality of client computersproviding access to the server; and a medical device manufacturercomputer being in data communications with the server wherein devicedata is managed to provide at least one functional group within amedical device manufacturer with highly relevant information derivedfrom the medical device performance data for use in product or serviceimprovement actions.
 42. The system of claim 41, in which the functionalsub-group is one of: research and development, product planning, postmarket surveillance, and sales and marketing.
 43. The system of claim41, in which the other information users include one of diseasemanagement organizations and healthcare management organizations.
 44. Asystem for implementing networked remote patient management servicescomprising: a server hosting high relevance patient management data forproviding chronic monitoring of the remote patients with chronic diseasehaving implantable medical devices and/or wearable devices; and saidserver being accessible via client computers wherein said clientcomputers include a web-enabled system, a medical device manufacturerweb-site, a physician site, a health care information network site, anda disease management organization; and each of said client computersbeing in data communications with the server to import specific data onwhich the patient management services billing schemes, for at least oneservice, are implemented.
 45. An internet-based method in a web-enabledsystem for a paid service to connect a remote patient to a databasenetwork for medical device data exchange and processing comprising thesteps of: providing a web-site in a web-enabled system, the web-sitehaving a user interface which includes a secure sign-in input to accessa database network site associated with said web-enabled system;automatically receiving at the database network site first data inputsuniquely associated with a specific medical device and patient usingsaid medical device; receiving at the web-site second data inputsrequesting access to representations of said first data inputs;confirming the identity of the medical device, the patient, and theoriginator of said second data inputs; and enabling the originator ofsaid second data inputs to have access to the database to viewrepresentations of said first data inputs.
 46. An internet-based methodin a web-enabled system for a paid service to connect a remote patientto a database network for medical device data exchange and processingcomprising the steps of: providing a web-site in a web-enabled system,the web-site having a user interface which includes a secure sign-ininput to enable access to a database network site associated with saidweb-enabled system; periodically receiving at the database network sitefirst data inputs uniquely associated with a specific medical device andpatient using said medical device; receiving at the web-site second datainputs requesting access to representations of said first data inputs;confirming the identity of the medical device, the patient, and theoriginator of said second data inputs; and enabling the originator ofsaid second data inputs to have access to the database via the secureweb site to view representations of said first data inputs.